Artificial Pancreas Gains FDA Approval for Type 1 Diabetes

Approximately 1.25 million Americans suffer from type 1 diabetes (T1D), including 200,000 young people. In addition, some 40,000 Americans are diagnosed with T1D each year. (1) Unlike type 2 diabetes, which can be treated with many types of medications, depending on the triggers, T1D can only be treated with insulin therapy and can not be cured or reversed.

As a result, researchers have spent years trying to find the best ways for T1D patients to maintain consistent blood sugar levels. On September 28, the U.S. Food and Drug Administration helped T1D patients take a step closer to better health with the approval of the first artificial pancreas system—an automated insulin delivery device for T1D.

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According to the FDA press announcement, the Medtronic MiniMed 670G includes a sensor that attaches to the body to measure glucose levels under the skin; an insulin pump strapped to the body; and an infusion patch connected to the pump with a catheter that delivers insulin. Through clinical trials, the system was determined to be safe for people 14 years of age and older with type 1 diabetes. According to the FDA, “no serious adverse events, diabetic ketoacidosis (DKA), or severe hypoglycemia (low glucose levels) were reported during the study.” (2)

In fact, the new device is being called a game changer for those with T1D because it will “monitor glucose levels around the clock and automatically provide the right amount of insulin, and potentially other blood-sugar-stabilizing hormones, at the right time” (3) with little or no input from the user. The automation of blood sugar management is expected to dramatically reduce T1D-related risks and improve the lives of people who have the disease.

While details on the price of the device and insurance coverage are not readily available, one potential outcome is that fewer patients will require traditional diabetic testing supplies, so HME and DME providers will need to take note of this change and potentially adjust their business services accordingly.